Tags: Life Sciences
EU General Court bars patient association from challenging medicine authorisation refusal
In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.
Despite EU harmonisation, Member States may impose authorisation requirements on pharmacy-prepared medicines, rules EU Court of Justice
Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use). This includes “magistral formulae” (prepared in a pharmacy for an individual patient on prescription) and “officinal formulae” (prepared in a pharmacy in accordance with a pharmacopoeia and supplied directly to that pharmacy’s […]
EU General Court: technical vaccine data does not have to be disclosed on request
The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies’ commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).
Belgium’s healthcare plans for 2026 – and where pharma fits in
Every year, Belgium’s federal ministers publish their policy notes for discussion in Parliament. They give a high-level snapshot of what each minister plans to focus on in the coming year. For the pharmaceutical industry, the healthcare policy noteis usually the one to watch. Interestingly, the economic policy notealso weighs in on pharma this year. In this blog post, we unpack the key policy signals for the pharmaceutical sector and group them around three main pillars: budget, accessibility, andpricing.
Where food law meets intellectual property: Food IP through last year’s case law
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?
Belgian Parliament has adopted urgent 2026 healthcare budget measures: what’s the impact on the pharma industry?
Over the Christmas break, the Belgian Parliament adopted an urgent law with several measures linked to the approved 2026 healthcare budget, with effect from 1 January 2026. The law is intentionally limited to provisions that must enter into force immediately to ensure that the required savings and revenues are available from the start of the […]
EU Reaches Pharma Package Deal: Key Changes at a Glance
On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here). The reform seeks to update the EU’s pharmaceutical rulebook to facilitate access to safe and affordable treatments and bolster the life sciences sector’s competitiveness. While more detailed information is still trickling […]
Silent night, mighty right? The ascent of the variety denomination | Plant Variety Rights X-Mas Special – Part 2
Plant Variety Rights (PVR) quietly shape how new varieties reach our fields, kitchens and shop shelves. As we wrap up the year, it’s the perfect moment to reflect on what’s been cooking in the world of PVR. Building on last year’s insights, this year’s focus is on the increasing importance and enforcement of variety denominations—not […]
Belgian Constitutional Court strikes down pharma industry ‘unavailability contribution’
The Belgian Constitutional Court (“CC”), on 6 November 2025, annulled some provisions of the Law of 18 May 2024 containing various provisions on health and finance, striking down the pharma industry ‘unavailability contribution’. Background Parts of the above Law sought to protect patients from bearing additional costs when reimbursable medicines become unavailable and must be […]
Food Hygiene for Fish: EU General Court Requires Scientific Basis to “Clarify” the Law
Food company Mowi Poland successfully challenged the European Commission’s new hygiene rules governing ‘stiffening’—a specialised fish processing technique—on the grounds that the Commission failed to obtain mandatory scientific consultation. While the Commission defended its approach by characterising the measures as mere “clarification” of existing law and citing industry guidelines as support, the EU General Court […]
Combination therapies in Belgium: how to collaborate without breaching competition law
As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies—are becoming increasingly vital, especially in treating complex diseases like cancer. These therapies promise improved clinical outcomes through synergistic mechanisms of action. However, the reimbursement process for such therapies presents significant regulatory and legal challenges, particularly […]
LSS: Challenging Government Decisions: Legal Strategies in Agri-food & Life Sciences
Government decisions can often have a significant impact on companies in the agrifood and life sciences sectors. But what options do you have if you disagree with such a decision? Which steps are available to you, and which route – administrative or judicial – is the most suitable in your case?